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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

A toxicokinetics assessment was conducted for bismuth citrate using available data including data from the published literature. Based on the results of this assessment, the substance is considered to have low bioaccumulation potential.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential
Absorption rate - oral (%):
0.5
Absorption rate - dermal (%):
0.1
Absorption rate - inhalation (%):
9.4

Additional information

A toxicokinetics assessment was conducted for bismuth citrate using available data including data from the published literature.

Absorption:The bismuth portion of pharmaceutical preparations of bismuth citrate is poorly absorbed from the gastrointestinal tract with an oral bioavailability generally reported to be < 1%. There are very few data on the dermal absorption of bismuth, however, absorption via this route is expected to be low. Citrate is rapidly absorbed from the gastrointestinal tract with 96% to 98% absorbed within 3 hours.Based on particle size distribution data and modelling of deposition in the respiratory tract, it is estimated that between 5.0% and 9.4% of bismuth citrate may be absorbed via inhalation.

Distribution: The small amount of bismuth that is absorbed is distributed to various organs with the highest concentration expected to be in the kidney. The results of a study in guinea pigs with radiobismuth suggests poor placental transfer of bismuth (<1%), however, bismuth can cross the blood-brain barrier. The distribution half-life of bismuth is 1 to 4 hours and the plasma half-life is 5 to 11 days.

Elimination: Excretion of absorbed bismuth is via the urinary and faecal routes and the urinary excretion half-life lasts between 21 to 72 days. Unabsorbed bismuth is excreted in the faeces. Citrate is a byproduct of normal oxidative pathways in the body and is normally excreted in the urine.